Expert Details
Pharmaceutical Regulation, FDA Compliance & Inspections, Sterile Compounding, Quality Systems, and Regulatory Science
ID: 740506
California, USA
Expert has served in senior leadership roles within the FDA, including Director of Regulatory Management Review and Senior Program Management Officer, where they designed and managed national training programs for thousands of FDA investigators and regulatory professionals. Their expertise spans cGMP compliance, inspection readiness, quality assurance, and manufacturing process validation, with a focus on improving regulatory outcomes and public health safety.
As a consultant and executive, Expert has provided strategic regulatory guidance and compliance assessments to pharmaceutical and biotech firms, addressing FDA enforcement actions, facility readiness, and data integrity remediation. Expert has led teams in the development of electronic inspection tools, regulatory protocols, and international training curricula to modernize pharmaceutical oversight.
In addition to FDA leadership, Expert has maintained over 20 years of hospital pharmacy experience, applying sterile compounding and pharmacotherapy expertise in clinical settings. They have also served as Vice Chair for a national pharmacy specialty board and as adjunct faculty for a university school of pharmacy, advancing education in regulatory science and compounding standards.
Expert is a frequent speaker and author in the field of pharmaceutical regulation, contributing to international conferences and publications on inspectional innovation, compounding transformation, and quality management systems. Their career reflects a sustained commitment to regulatory excellence, industry advancement, and the protection of public health.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2002 | Degree: Pharm.D. | Subject: Pharmacy | Institution: University of Southern California |
| Year: 2002 | Degree: MS | Subject: Regulatory Science | Institution: University of Southern California |
| Year: 1997 | Degree: BS | Subject: Biology | Institution: University of California, Irvine |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2023 to 2024 | Employer: Wynngate Corporation | Title: CEO/President | Department: |
Responsibilities:• Provided regulatory and technical consulting in biopharmaceutical compliance, facility readiness auditing, and CMC assessments.• Conducted audits for biologics, pharmaceuticals, 503A/B compounding pharmacies, PET facilities, APIs, OTC drugs, and dietary supplements. • Delivered training and education in CGMP audit readiness and compliance case development. |
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| Years | Employer | Title | Department |
| Years: 2023 to 2024 | Employer: Lachman Consulting Services | Title: Senior Director | Department: |
Responsibilities:• Led client engagements involving regulatory compliance, manufacturing, and FDA submission support.• Managed quality systems and compliance remediation including FDA 483 and warning letter responses. • Conducted due diligence, gap analyses, and validation assessments for pharmaceuticals, biologics, and medical devices. • Oversaw training, mentoring, and development of personnel while leading consulting teams. |
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| Years | Employer | Title | Department |
| Years: 2019 to 2023 | Employer: FDA | Title: Senior Program Management Officer | Department: Office of Training, Education, and Development |
Responsibilities:• Served as pharmaceutical subject matter expert to lead and restructure national FDA pharmaceutical training programs for over 2,000 investigators and regulators.• Developed and instructed courses on GMP topics, data integrity, combination products, and foreign supplier verification. • Created digital training platforms and instructional materials for domestic and international inspectional programs. |
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| Years | Employer | Title | Department |
| Years: 2016 to 2019 | Employer: FDA | Title: Director Regulatory Management Review Officer | Department: Office of Pharmaceutical Quality |
Responsibilities:• Serve as a Senior Consumer Safety Officer and Advisor for Center for Drug Evaluation and Research (CDER) of FDA in providing subject matter expertise in drug regulation interpretation pertaining to and impact on drug quality, manufacturing, and control worldwide• Achieve 100% target dates of dossiers preparation for over 200 domestic and foreign firms for 3 consecutive years to assist investigators with firm’s intelligence data prior to conducting inspections (2019 CDER Recognition Honor Award) • Manage drug quality signals through incidents, global watch, and field alert reports to enhance surveillance of potential public health drug safety issues related to CDER-regulated products • Represent FDA on interagency, national and international committees and forums and represent CDER at professional meetings (i.e. Parenteral Drug Association) with regulated industry and with Federal and State regulatory bodies • Provide remote assessment of firm’s manufacturing quality through Food and Drug Safety and Innovation Act (FDASIA) 706 request for records remotely instead of being on site for firms at high risk travel locations • Manage, query, and triage incidents reported from industries and consumers globally • Advisor for Center of Compounding Excellence to develop training courses for industry • Team lead to develop Positron Emission Inspection Protocol (PET IP) and advisor to create New Inspection Protocol Projects for other drug inspections |
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| Years | Employer | Title | Department |
| Years: 2014 to 2016 | Employer: FDA | Title: Sr. Supervisory Management Officer | Department: Office of Global Regulatory Operations and Policy |
Responsibilities:• Managed an inspectional budget of approximately $20 million• Was the most productive drug supervisor to lead the team of 12 drug specialists to achieve the highest numbers of inspections with regulatory actions and zero employee attrition for 3 consecutive years (e.g. 240 inspections average per year in my group vs. 130 on average per year for other drug groups and attrition rate was about 50% among 7 other drug groups) – this led to a reduction of about 50% of the generic drugs back log (was awarded for FDA Outstanding Service Award) • Trained, mentored, coach, and audit over 30 drug specialists within GDUFA and also international drug specialist (awarded for FDA Outstanding Service Award) • Performed all administrative and management activities for GDUFA team including hiring of 80 GDUFA employees • Responsible for technical and quality review of work product prior to submission to Compliance Branch • Reviewed and approved the design, selection, acquisition, and utilization of major investigational and inspectional equipment for a yearly budget of approximately $100,000 • Advisor/Co-author for Compressed Medical Gas Compliance Program Guidance Manual update • Conduct on the job training for new hire investigators • Conduct inspections to meet inspection work plan |
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| Years | Employer | Title | Department |
| Years: 2002 to 2014 | Employer: FDA | Title: Pharmaceutical Inspectorate | Department: Office of Global Regulatory Operations and Policy |
Responsibilities:• Planned, conducted and directed highly technical, complex and multi-faceted inspections & in-depth investigations of pharmaceutical and biotech companies – drug subject matter expert for the District• Over 50 regulatory actions such as warning letters, application withhold recommendations, and industry meeting resulted from my inspections (awarded for PHS Outstanding Service Medal in 2015 for national recall of 10 different injectable drug products with potential particulate matter contamination) • Acted as team lead and instructor on conducting complex drug manufacturing firms • Conducted over 50 pre-approval inspections for new drug applications and abbreviated drug applications of human and animal drugs (CMC and GMP review) • Led team to coordinate, moderate, and train Basic Drug Course • Served as a drug expert witness in cases dealing with regulated products • Conducted international inspection as a Foreign Cadre Member • Conduct level II drug audits of investigators • Monitor Drug Quality Reporting System for Los Angeles District Office |
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| Years | Employer | Title | Department |
| Years: 2002 to 2023 | Employer: Fountain Valley Regional Hospital and Medical Center | Title: Pharmacist | Department: Pharmacy |
Responsibilities:• Part time clinical pharmacy practice of 50 hours average per month• Manage with other pharmacists on drug pharmacy inventory of approximately $2 million per month • Oversee and precept pharmacy technicians, interns, and residents • Verify, enter, and check oral and intravenous orders and medications prior to dispensing • Make clinical rounds and medication interventions based on patient’s specific parameters • Write and compound total parenteral nutrition (TPN) order and monitor patient’s health status • Consult physicians, nurses, and dietitian to provide appropriate drug/TPN therapy • Adjust and/or substitute drug and drug dosages in renally and hepatically impaired patients including Heparin, Warfarin, Epoetin, Vancomycin, Aminoglycoside, and other drugs requiring dosing • Train nurses how to use Cerner to input orders • Consult patients with take home medications and control narcotic inventory • Perform medication evaluation and reconciliation based on patient’s medical history and current condition • Work in Telemetry, Emergency, Surgical, Orthopedic, Intensive Care, and Pediatric units • Assist in hospital vaccination of employees annually • Ensure sterile compounding practice meets the requirements of USP |
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| Years | Employer | Title | Department |
| Years: 2020 to 2023 | Employer: Board of Pharmacy Specialty in Sterile Compounding Pharmacy | Title: Vice Chair/Council Member | Department: |
Responsibilities:• Advisor for Board of Pharmacy Specialty in Sterile Compounding Pharmacy Certification• Write exam questions and make recommendations on questions written • Work with Board members on advancing certification process • Ensure sterile compounding practice meets the requirements of USP and |
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Additional Experience
| Expert Witness Experience |
|---|
| Expert has served as a pharmaceutical subject matter expert and regulatory witness in cases involving FDA-regulated products, compounding practices, and GMP compliance. Experienced in inspection documentation, FDA-483 analysis, and testimony on manufacturing quality and compliance systems. He has participated in multiple regulatory enforcement proceedings and case reviews within the FDA. |
Career Accomplishments
| Associations / Societies |
|---|
| • Board of Pharmacy Specialty in Sterile Compounding Pharmacy (Vice Chair, Council Member) • Orange County Regulatory Affairs Discussion Group (Conference Chair/Presenter) • Parenteral Drug Association (Presenter/Panelist) |
| Licenses / Certifications |
|---|
| • California Registered Pharmacist, RPh • Board Certification in Sterile Compounding Pharmacy (2020–2026) • ACLS and BLS Certifications (American Heart Association, 2022) • Level III Pharmaceutical Inspectorate Certification (2010) • Level II Drug Auditor Certification (2010) • Level I Drug Certification (2003) |
| Awards / Recognition |
|---|
| • FDA Outstanding Service Awards for discovery of contaminated injectable drugs and inspectional innovation. • Commissioner’s Special Citation for public health protection during 2012 meningitis outbreak. • Multiple FDA commendations for electronic inspection systems and removal of unsafe drugs. |
| Publications and Patents Summary |
|---|
| • Publications: 5 • Presentations: Over 30 (national and international) |